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news.The FDA has granted Johnson & Johnson's antibiotic Levaquin an additional six months of marketing exclusivity on the basis studies showing its efficacy and safety in children.
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The decision was based on five, company-sponsored pediatric studies conducted at the request of the FDA, according to J&J. The extension gives the company marketing exclusivity on Levaquin until June 2011.
The studies included trials to determine the pharmacokinetic profile and the efficacy and safety of the drug in children with community-acquired pneumonia and recurrent and/or persistent acute otitis media.